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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

HbA1c, Lyophilised hemolysate… — IVDD — General IVDD

MD Atlas
Streekziekenhuis Koningin Beatrix

EUDAMED last updated this device on May 25, 2026

HbA1c, Lyophilised hemolysate Level Low

B-87205897081982

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Streekziekenhuis Koningin Beatrix
UDI-DI code: 87205897081982
Reference / catalog number: HBA-02.1 CV

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Manufacturer information

Organization name: Streekziekenhuis Koningin Beatrix
SRN: NL-MF-000000427
Manufacturer status: Active

Related devices

HbA1c, Frozen Whole BloodB-87205897082429WOn the market HbA1c, Frozen Whole BloodB-87205897082359ZOn the market HbA1c, Frozen Whole Blood setB-87205897080060On the market HBAFr-01.1B-87205897082118On the market HBAFr-01.2B-87205897082286On the market

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: HbA1c, Lyophilised hemolysate Level Low
UDI-DI code: 87205897081982
Basic UDI-DI: B-87205897081982
Reference / catalog number: HBA-02.1 CV
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Intended purpose HbA1c, lyophilised hemolysate is a non-automated in vitro diagnostic medical device intended to be used by healthcare professionals as a reference material in HbA1c measurement procedures for the quantitative measurement of HbA1c in blood. The material is intended to support calibration or quality control procedures in HbA1c assays used for monitoring glycaemic control and treatment response in patients with diabetes. Disclaimer: This product shall not be used as a calibrator or control material for devices used in the diagnosis of diabetes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
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Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0101050302CALIBRATORS SINGLE COMPONENT (CC)
W0101050205DIABETES CONTROLS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.